YUBIOLOGICS Receives IND Approval for Phase 3 Clinical Trial of Botulinum Toxin Product ‘ATGC-100’

[Asia Economy Reporter Yoo Hyun-seok] YUBIOLOGICS announced on the 23rd that its botulinum toxin formulation ‘ATGC-100ju’, co-developed with ATGC, has received approval for Phase 3 IND from the Ministry of Food and Drug Safety.

The Phase 3 clinical trial is scheduled to be conducted at three institutions: Nowon Eulji University Hospital, Hanyang University Hospital, and Chung-Ang University Hospital. It will compare the efficacy and safety of ‘ATGC-100ju’ with Allergan’s ‘Botox-ju’ in hundreds of adults requiring improvement of moderate to severe glabellar lines.

‘ATGC-100ju’ is a product equivalent to ‘Botox-ju’. Since March last year, the two companies have conducted Phase 1/2 clinical trials in Korea, comparing the safety and efficacy of ‘ATGC-100ju’ and ‘Botox-ju’ in adult patients needing glabellar line improvement. The safety of ‘ATGC-100ju’ was confirmed in the Phase 1 clinical trial. Additionally, in the Phase 2 clinical trial, ‘ATGC-100ju’ demonstrated equivalent glabellar line improvement effects to ‘Botox-ju’ without any toxicity issues related to the drug.

A YUBIOLOGICS official stated, “We plan to complete the Phase 3 clinical trial of ‘ATGC-100ju’ by the end of this year and launch it domestically next year,” adding, “We also plan to obtain export approval for ‘ATGC-100ju’ within this year and proceed with overseas exports.”

Currently, YUBIOLOGICS supplies oral cholera vaccines to UNICEF and is conducting Phase 3 clinical trials for typhoid vaccines, as well as Phase 1 clinical trials for pneumococcal and meningococcal vaccines. In the future, the company plans to develop premium vaccines such as shingles and RSV vaccines.

This content was produced with the assistance of AI translation services.